Benefits of Zejula

Maintenance Treatment of Recurrent Ovarian Cancer

ZEJULA works to slow the return or progression of cancer1,2

ZEJULA is a PARP inhibitor, which means it can help prevent cancer cells from repairing their damaged DNA. This may slow the return or the progression of cancer. ZEJULA can also affect other cells and tissues in the body.1,3
 

In the NOVA trial, ZEJULA helped women with and without an inherited BRCA mutation1

ZEJULA was evaluated as a maintenance treatment in a double-blind, placebo-controlled phase 3 trial of 553 women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who1*

  • Received at least 2 platinum-based chemotherapy treatments, and
  • Had a complete or partial response to the most recent chemotherapy

The study was designed to measure how long women lived with epithelial ovarian, fallopian tube, or primary peritoneal cancer without their disease getting worse. The treatment benefit of ZEJULA was independently studied in women with an inherited BRCA mutation and without an inherited BRCA mutation.1

The women who took part in the clinical trial were divided into 2 groups based on BRCA status. Women with an inherited change (also called a mutation) in the BRCA gene were in 1 group. Women without the inherited change in the BRCA gene were in the other group.1,4

ZEJULA clinical study included both BRCA-positive and BRCA-negative cohorts of women
ZEJULA clinical study included both BRCA-positive and BRCA-negative cohorts of women

ZEJULA offered more time without progression, regardless of BRCA status

ZEJULA offered nearly 4X more time in response for women with an inherited BRCA mutation vs watch and wait (placebo)1

The clinical trial of ZEJULA measured median progression-free survival, or PFS, between women taking ZEJULA compared to placebo. PFS means the length of time during and after treatment that you live with cancer but it does not get worse.1,2,5


Women who had an inherited BRCA mutation

Length of time during and after treatment that BRCA-positive women lived without their cancer getting worse
Length of time during and after treatment that BRCA-positive women lived without their cancer getting worse

Women who did not have an inherited BRCA mutation

Length of time during and after treatment that BRCA-negative women lived without their cancer getting worse
Length of time during and after treatment that BRCA-negative women lived without their cancer getting worse

Information from the 2 groups (those with and those without an inherited BRCA mutation) was analyzed. In the group with women with an inherited BRCA mutation, it was estimated that half of the women who received ZEJULA experienced disease progression after 21.0 months compared with 5.5 months for women who received placebo. Similarly, for the women without an inherited BRCA mutation, the analysis estimated that half of the women who took ZEJULA experienced disease progression after 9.3 months compared with 3.9 months for those who took placebo. These halfway points are referred to as median progression-free survival.1

Median is the middle number in a set of data, also called the midpoint. It means that half of the numbers are greater than the median and half are less.6

Women taking ZEJULA had less risk of disease progression compared to placebo

The risk of progression decreased by1:

74 percent

for women who had an inherited BRCA mutation

55 percent

for women without an inherited BRCA mutation

Not all women in the clinical study responded to ZEJULA.

Treatment of Advanced OVARIAN CAncer

ZEJULA is also a treatment for eligible women with advanced ovarian, fallopian tube, and primary peritoneal cancer1

ZEJULA is FDA approved as a treatment for women who have had at least 3 prior chemotherapy regimens.

A certain “BRCA” gene mutation 4,7-9


A positive laboratory test, and whose cancer was in response to treatment with

platinum-based chemotherapy, and who have progressed more than 6 months after the last treatment.10-13

ZEJULA is FDA approved as a treatment for women who have had at least 3 prior chemotherapy regimens.

 

A certain “BRCA” gene mutation 4,7-9

 

 

A positive laboratory test, and whose cancer was in response to treatment with

platinum-based chemotherapy, and who have progressed more than 6 months after the last treatment.10-13

Your healthcare provider will perform a test to make sure that ZEJULA is right for you.1

The study was designed to measure how well women living with advanced ovarian cancer responded to treatment with ZEJULA.

Response to ZEJULA treatment was seen in HRD-positive women, which included women with an inherited BRCA mutation, as well as those who tested positive for a laboratory test, whose cancer was in response to treatment with platinum-based chemotherapy1,14,15

Half of women who responded saw a duration of response of greater than 8 months while taking Zejula1

Half of women who responded saw a duration of response of greater than 8 months while taking ZEJULA.
Half of women who responded saw a duration of response of greater than 8 months while taking ZEJULA.

The duration of response is the time from the cancer responding to the treatment until the cancer progresses.16

 

24% of women responded to ZEJULA and had tumors that reduced in size1

24% of women responded to ZEJULA and had tumors that reduced in size.

A response shows if a patient had a reduction in their tumors while on treatment. If some, but not all, of the cancer disappears, it is a partial response. If there are no remaining clinical signs of cancer, it is considered a complete response, although this does not always mean that the cancer has been cured.17,18

 

The safety profile of ZEJULA for the treatment of advanced ovarian cancer was consistent with another clinical trial that studied ZEJULA1

Please see full Prescribing Information and Important Safety Information below to learn more.

ZEJULA can
be an option

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Commonly
Used Terms

Get more detailed definitions of commonly used terms in ovarian cancer treatment

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References: 1.ZEJULA [package insert]. Waltham, MA: GSK, Inc.; October 2019. 2. Mirza MR, Monk BJ, Herrstedt J, et al; for the ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164. 3. Sandhu SK, Schelman WR, Wilding G, et al. The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2013;14(9):882-892. 4. NCI Dictionary of Cancer Terms: BRCA. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/search?contains=false&q=BRCA. Accessed January 3, 2020. 5. NCI Dictionary of Cancer Terms: progression-free survival. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/progression-free-survival. Accessed January 3, 2020. 6. Median. Merriam-Webster website. https://www.merriam-webster.com/dictionary/median. Accessed January 3, 2020. 7. BRCA mutations: cancer risk and genetic testing. National Cancer Institute website. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet. Accessed January 3, 2020. 8. NCI Dictionary of Cancer Terms: germline mutation. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/germline-mutation. Accessed January 3, 2020. 9. NCI Dictionary of Cancer Terms: somatic mutation. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation. Accessed January 3, 2020. 10. Frey MK, Pothuri B. Homologous recombination deficiency (HRD) testing in ovarian cancer clinical practice: a review of the literature. Gynecol Oncol Res Pract. 2017;4:4. doi:10.1186/s40661-017-0039-8. 11. Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D'Andrea AD. Homologous recombination deficiency: exploiting the fundamental vulnerability of ovarian cancer. Cancer Discov. 2015;5(11):1137-1154. 12. Chemotherapy. Ovarian Cancer Research Alliance website. https://ocrfa.org/patients/about-ovarian-cancer/treatment/chemotherapy. Accessed January 3, 2020. 13. NCI Dictionary of Cancer Terms: platinum. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/platinum. Accessed January 3, 2020. 14. Anemia. National Heart, Lung, and Blood Institute website. https://www.nhlbi.nih.gov/health-topics/anemia. Accessed January 3, 2020. 15. NCI Dictionary of Cancer Terms: hemoglobin. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hemoglobin. Accessed January 3, 2020. 16. U.S. Department of Health and Human Services, Food and Drug Administration. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry. https://www.fda.gov/media/71195/download. Published December 2018. Accessed January 3, 2020. 17. NCI Dictionary of Cancer Terms: remission. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/remission. Accessed January 3, 2020. 18. NCI Dictionary of Cancer Terms: response. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/response. Accessed January 3, 2020.

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